RepurpoSing Old Drugs TO SuppRess a Modern Threat: The STORM Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time Free of Either Hospitalization, Hypoxemia, ICU Admission or Death
研究概览
简要总结
The primary aim of this study is to test whether Doxycycline can benefit patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections by inhibiting the replication of the virus while at the same time blocking the development of cytokine storms or inhibiting cytokine-associated coagulopathy respectively. The investigators hypothesize that Doxycycline will will improve survival and reduce morbidity in SARS-CoV-2 infected patients.
A secondary aim is to identify genetic variants that predict either an unusually mild disease or an unusually severe disease - knowledge that can be used to design new and precise medications and to be able to predict patients who might get into early trouble and to therefore hospitalize them.
详细描述
This study will randomize 20 patients with confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to Doxycycline (100 mg BID) or Placebo and then assess the progression of their disease over the next three weeks with the primary endpoint being days alive and out of the hospital.
The investigators will collect specimens for measurement of viral burden (nasopharyngeal luminex (SARS-CoV-2), SARS-CoV-2 serum quantitative viral load, SARS-CoV-2 IgM/IgG antibodies), markers of inflammation (WBC, ESR, TNFa, IL-1, IL-6, IL-1B), and cardiac dysfunction (CRP, pro-BNP, hsTnT).
Eligibility will be based on history and physical examination findings - collated into a clinical suspicion score. The decision to enroll based on clinical suspicion score rather than confirmed SARS-CoV-2 disease is based on the variable and unacceptably high false negative rate of the nasopharyngeal PCR test for in early disease.
Clinical Suspicion Score: Greater than or equal to 6/20 (at least 4 points of which must be clinical) will be eligible for enrollment.
Clinical Criteria: Max 12 points
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), disease with clinical suspicion score >6/20, not requiring hospitalization
- •Age ≥18 years
- •Willing to sign the informed consent form
- •Willing to take study drug or placebo as directed for 21 days
排除标准
- •Confirmed or highly suspected early stage severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), disease with clinical suspicion score >6/20, requiring hospitalization
- •Suspected or confirmed convalescent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), within the prior 4 weeks
- •Age <18 years' old
- •Inability to take medications orally
- •Inability to provide written consent
- •Known sensitivity/allergy to doxycycline or tetracyclines
- •Current use of doxycycline for another indication
- •Pregnancy
- •A known diagnosis of myasthenia gravis
- •History of Clostridium Difficile infection within past 12 months
- •Sun sensitivity
- •Individuals using medications which could lower doxycycline levels, including barbiturates, phenytoin, carbamazepine, warfarin
- •Individuals using isotretinoin
研究组 & 干预措施
Doxycycline
Participants receive 100 MG BID for 21 days
干预措施: Doxycycline (Drug)
Placebo
Participants receive Placebo BID for 21 days
干预措施: Placebo (Drug)
结局指标
主要结局
Time Free of Either Hospitalization, Hypoxemia, ICU Admission or Death
时间窗: 21 days
Days Alive and Out of Hospital (Composite Endpoint)
次要结局
- IL-6(21 days)
- NP SARS-CoV-2 PCR(21 days)
- SARS-CoV-2 Serum Quantitative Viral Load(21 days)
- SARS-CoV-2 IgM/IgG Antibodies(21 days)
- White Blood Cell Count (WBC)(21 days)
- N-Terminal Pro-B-Type Natriuretic Peptide (Pro-BNP)(21 days)
- High Sensitivity Troponin I (hsTnT)(21 days)
- Tumor Necrosis Factor Alpha (TNF-a)(21 days)
- IL-1(21 days)
- Absolute Lymphocyte Count (ALC)(21 days)
- C-Reactive Protein (CRP)(21 days)
- IL-1B(21 days)